Tramadol Hydrochloride

Product NDC: 53002-4321
11-digit product format: 530024321
Labeler code: 53002
Product ID: 53002-4321_0540af6a-bdcd-4694-9dfd-6e96851ff6f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA091498
Marketing category: ANDA
Marketing start: 2015-05-22
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-4321		I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4321	53002-4321-1	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4321	53002-4321-2	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4321	53002-4321-3	I	Inactivated by FDA	2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 68 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4321-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4321-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4321-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4321-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4321-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4321-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4321-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4321-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4321-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4321-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4321-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4321-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4321-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4321-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4321-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4321-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4321-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4321-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4321-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4321-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4321-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4321-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4321-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4321-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4321-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4321-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4321-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-4321-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-4321-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-4321-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-4321-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-4321-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-4321-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-4321-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-4321-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-4321-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-4321-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-4321-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-4321-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-4321-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-4321-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-4321-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-4321-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-4321-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-4321-1	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091498-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2013-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091498-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091498-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091498-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091498-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091498-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091498-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091498-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091498-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091498-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091498-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091498-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091498-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091498-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091498-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091498-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091498-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091498-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091498-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091498-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091498-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091498-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091498-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091498-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091498-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091498-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091498-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091498-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091498-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091498-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091498-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091498-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091498-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091498-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091498-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091498-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091498-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091498-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091498-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091498-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091498-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091498-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-4321-1	2023-01-30	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-2	2023-01-30	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-3	2023-01-30	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-1	2020-12-17	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-2	2020-12-17	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-3	2020-12-17	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-1	2020-01-31	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-2	2020-01-31	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995
53002-4321-3	2020-01-31	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-4321-1	Tramadol Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	3
53002-4321-2	Tramadol Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	3
53002-4321-3	Tramadol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-4321	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20201218_5f4105f7-be41-4863-8245-f39594672c65.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	1d4af58f-17f3-4cbd-870c-098ace954872	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091498 application number: ANDA091498

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835603	traMADol HCl 50 MG Oral Tablet	PSN	5f4105f7-be41-4863-8245-f39594672c65	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	5f4105f7-be41-4863-8245-f39594672c65	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-4321-1	53002432101	10 TABLET, FILM COATED in 1 BOTTLE (53002-4321-1)	2018-10-01	0000-00-00	No	No	Current
53002-4321-2	53002432102	20 TABLET, FILM COATED in 1 BOTTLE (53002-4321-2)	2018-10-01	0000-00-00	No	No	Current
53002-4321-3	53002432103	30 TABLET, FILM COATED in 1 BOTTLE (53002-4321-3)	2018-10-01	0000-00-00	No	No	Current